FDA Device Registration & Listing · Stratford, CT, US · Registration 2246990
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2019-12-06 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EJI | Syringe, Cartridge | Dental | Class 2 | 872.6770 | 2013-01-29 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2012-11-12 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2012-11-12 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2012-11-12 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2012-11-12 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2017-09-14 |
| EIK | Carver, Wax, Dental | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2012-11-12 |
| ECR | Setter, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2008-03-24 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EKH | Carver, Dental Amalgam, Operative | Dental | Class 1 | 872.4565 | 2017-11-20 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2009-02-17 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2008-06-11 |
| EFK | Forceps, Articulation Paper | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EMO | Knife, Periodontic | Dental | Class 1 | 872.4565 | 2009-07-01 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2012-11-12 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2008-09-26 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2012-11-12 |
| LCN | Scraper, Tongue | Dental | Class 1 | 872.6855 | 2008-09-19 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2008-05-12 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2010-12-16 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2012-11-12 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2012-11-12 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 2012-11-12 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2012-11-12 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2012-11-12 |
| GWY | Pinwheel | Neurology | Class 1 | 882.1750 | 2009-05-12 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2012-11-12 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2012-11-12 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2009-03-12 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2019-12-06 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2019-12-04 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2008-06-05 |
| EJZ | Knife, Margin Finishing, Operative | Dental | Class 1 | 872.4565 | 2009-07-01 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2012-11-12 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2009-02-17 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2007-12-03 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2012-11-12 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2011-12-20 |
No official correspondent registered.
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| K040797 | Britesmile, Inc. | BRITESMILE MASKING CREAM | 2004-04-02 |
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K851721 | Artiberia | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | 1985-07-02 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0039-2018 | Teleflex Medical | 1 | Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. |
| Z-0013-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0014-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0015-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0016-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005809810 | Jarit GmbH | Rietheim-Weilheim Baden-Wurttemberg, DE |
| 1625507 | MEDTRONIC POWERED SURGICAL SOLUTIONS | FORT WORTH, TX, US |
| 1061927 | INTERNATIONAL STERILIZATION LABORATORY, LLC | GROVELAND, FL, US |
| 1834331 | PARAGON MEDICAL, INC. | PIERCETON, IN, US |
| 9680619 | SMT SCHILLING METALLTECHNIK GMBH | MUHLHEIM Baden-Wurttemberg, DE |
2246990 when referencing this establishment in official correspondence.